Validation of a hand-held Ultrasound device in the evaluation of Aortic Stenosis

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Abstract

Purpose Hand-held ultrasound devices (HHUD) are increasingly used in routine clinical practice, though they lacked continuous (CW) Doppler capability until recently. There is limited evidence on the utility of HHUD in assessing aortic stenosis (AS) in real-world settings. Our goal is to validate a new HHUD with CW Doppler assessing AS hemodynamic severity. Methods An observational, single-center study was conducted with patients diagnosed with AS. Following a reference echocardiographic study in the cardiac imaging laboratory, a HHUD with CW Doppler (Kosmos, EchoNous™) was used by an operator with intermediate echocardiography experience (American Society of Echocardiography, level II). The focus was on measuring aortic transvalvular Doppler velocities. Agreement between the mean trans-aortic gradient (mAG) was assessed using the intraclass correlation coefficient (ICC) test. A total of 101 patients were included. Results The reference test obtained a mAG of 29 mmHg (19.8–42.2), while the HHUD test showed 27.2 mmHg (16.2–43.9). A strong correlation was observed (r = 0.89), with an ICC value of 0.87 and no significant bias (1.61 ± 0.9). The HHUD demonstrated excellent ability to identify severe AS (kappa = 0.81, 95% CI 0.68–0.94; global agreement 92.1%). Agreement was lower in patients with obesity, poor acoustic windows, or atrial fibrillation. Conclusions The HHUD showed good agreement with standard echocardiography in assessing AS. While it slightly underestimated mAG, it was accurate enough to reliably quantify AS severity.

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